🔍 RecallPedia

Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE

Class I - Dangerous
🏥 Medical Devices Recalled: December 28, 2023 Cardinal Health 200 Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI/DI 26971564466244 (Case), 16971564466247 (Box),06971564466240 (Each), Lot Numbers: 230501, 230601 and 230602
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Cardinal Health 200, LLC
Reason for Recall:
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE

Product Codes/Lot Numbers:

UDI/DI 26971564466244 (Case), 16971564466247 (Box),06971564466240 (Each), Lot Numbers: 230501, 230601 and 230602

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0849-2024

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Cardinal Health 200

Class I - Dangerous

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Cardinal Health 200

Class I - Dangerous

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Cardinal Health 200

Class I - Dangerous

Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.

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